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Effect of ZenRest™ Lotus Seed & Rice Germ Extract Blend on Sleep Quality in Menopausal Women

NCT07678359 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-01

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if ZenRest™ (Lotus Seed \& Rice Germ Extract Blend) can help improve sleep quality in menopausal women aged 40-65 with mild-to-moderate sleep complaints.

The main questions it aims to answer are:

* Does taking ZenRest™ daily improve subjective, participant-reported sleep quality compared to a placebo?
* Does ZenRest™ improve objective sleep metrics, specifically sleep efficiency, when monitored via an Oura Ring wearable device?
* Does the extract improve secondary sleep and lifestyle factors, such as insomnia severity, daytime sleepiness, and vitality? Researchers will compare ZenRest™ to a placebo (a look-alike capsule that contains no active ingredients) to see if the botanical blend has a measurable effect on sleep quality.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lotus Seed & Rice Germ Extract

A proprietary blend of Lotus Seed Extract (Nelumbo nucifera) standardized to contain Neferine \>/=2.0% and Isoquercitrin \& Hyperoside \>/=0.5%, and Rice Germ Extract (Oryza sativa) providing Polyamines \>/=0.5% calculated as spermidine. Administered as a 50 mg capsule taken orally once daily, 30-60 minutes before bedtime, for 6 weeks (42 days).

OTHER

Placebo

An identical, matching inactive look-alike capsule containing microcrystalline cellulose. Administered orally once daily, 30-60 minutes before bedtime, for 6 weeks (42 days).

Sponsors & Collaborators

  • Alethios, Inc.

    collaborator INDUSTRY

  • Nutraland USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Dr. Bill Clark, PhD · Natprologix, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2026-09-30
Completion
2026-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07678359 on ClinicalTrials.gov